Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis

Not Applicable

• Conditions: Knee Osteoarthritis

• Registration Number: NCT04138784
• Lead Sponsor: Universidad de Granada

Brief Summary

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

Detailed Description

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Study Start: 2019-12
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
• Women aged older than 65 years
• Pain predominantly over the last 3 months
• Kellgren and Lawrence score ≥2.

Exclusion Criteria

• Ankle, hip or foot severe disorders
• Chronic back pain
• Alzheimer's disease, Parkinson's disease, motor neuron disorders.
• Diabetes mellitus
• Cardiac or respiratory insufficiency
• Inability to understand the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Functionality	Baseline, 8 weeks, 3 months	Changes in Functionality is going to be assessed by the Western Ontario and McMaster Universities (WOMAC). Scores range from 0 to 96, with higher scores indicating greater disease severity.
Changes in Physical Performance	Baseline, 8 weeks, 3 months	Changes in Physical Performance is going to be assessed by The Timed up ad go. It involves a person standing from a 46-cm-high chair, walking 3 m, turning, walking back to the chair and sitting down.
Changes in Perceived Health Status	Baseline, 8 weeks, 3 months	Changes in Perceived Health Status is going to be assessed by the EuroQol-5D.It contains two sections, a descriptive section and a valuation section. The descriptive section is a health status classification instrument with the following five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. In the second section, respondents are asked to value their overall health status on a visual analogue scale ranging from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state)